Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT03624556
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2018-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Exploratory Research Study of EGCG Use and Safety (PERSEUS)
Sponsor:
Parc de Salut Mar
Organization:
Study Overview
Official Title:
Pediatric Exploratory Research Study of EGCG Use and Safety (PERSEUS)
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERSEUS
Brief Summary:
To evaluate safety and tolerability of epigallocatechin gallate (EGCG) in children from 6 to 12 years old with Intellectual Developmental Disorders (IDD) (Down syndrome or Fragile X syndrome).
Detailed Description:
This project first objective is to evaluate the safety and tolerability of the EGCG molecule (extracted form green tea) on children from 6 to 12 years old with Intellectual Development Disorder (Down syndrome and Fragile X syndrome).
The secondary objective is to evaluate the benefits of the EGCG on attention, memory, executive functions, language and adaptive behaviour of these children. Dyrk1A and homocysteine in plasma will also be quantified, using them as biomarkers of efficacy.
The secondary objective is to evaluate the benefits of the EGCG on attention, memory, executive functions, language and adaptive behaviour of these children. Dyrk1A and homocysteine in plasma will also be quantified, using them as biomarkers of efficacy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: